FOOD
AND DRUG ADMINISTRATION
CENTER
FOR DRUG EVALUATION AND RESEARCH (CDER)
Cardiovascular
and Renal Drugs Advisory Committee
Meeting
Chair, Cardiovascular and Renal Drugs
Advisory Committee
Conflict of Interest
Statement Dornette
Spell-LeSane, M.H.A., NP-C
Executive
Secretary, FDA
Division
of Cardiovascular and Renal Drugs,
FDA
The committee will discuss whether aspirin should
be recommended for primary prevention of myocardial infarction. Professional
labeling for aspirin currently recommends its use for prevention of a second
myocardial infarction.
Introduction Erica
Peitler, RPh
Bayer
HealthCare LLC
Aspirin
Benefit/Risk in Primary Prevention Thomas
Pearson, M.D., M.P.H., Ph.D.
Safety/Efficacy
in Moderate Risk Colin
Baigent, M.D.
Population
Aspirin
Use in Women C.
Noel Bairey Merz, M.D.
Cedars-Sinai Medical Center
Los
Angeles, CA
Cardiovascular
and Renal Drugs Advisory Committee
Meeting
Sponsor
Presentations Cont.
Aspirin
Utilization Randall
Stafford, M.D., Ph.D.
Aspirin
in Clinical Practice Eric
Topol, M.D.
The
Regulatory History of
Aspirin
Michelle
M. Jackson, Ph.D.
Interdisciplinary Scientist,
Microbiologist
Division of Over-The-Counter
Drug Products, FDA
Statistical Analyses of the Chenxiong
(Charles) Le, Ph.D.
Bayer’s Citizens Petition Statistician
Division of Biometrics I,
Office of Biostatistics,
Office of Pharmacoepidemiology and Statistical
Science, FDA
11:15
– 12:00 Committee
Discussions/Questions to the FDA